US9636499B2 - Lead delivery device and method - Google Patents

Abstract

A medical apparatus includes a guidewire and a fixator catheter. The fixator catheter comprises a tubular body with a distal portion and a proximal portion, and further includes a distal opening, a fixator secured to the distal portion, and a body opening arranged between the fixator and the proximal portion. The guidewire passes through the body opening and the distal opening of the fixator catheter. The fixator is movable between a compact configuration and an expanded configuration and, in the expanded condition, is capable of anchoring the guidewire and fixator catheter in a lumen of a blood vessel.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to U.S. patent application Ser. No. 11/468,910 filed on Aug. 31, 2006, which is a division of U.S. patent application Ser. No. 10/254,196, filed on Sep. 24, 2002, now U.S. Pat. No. 7,107,105.

The disclosures of the above applications are incorporated herein by reference.

INTRODUCTION

Various cardiac devices providing electrical stimulation, rhythm management, or resynchronization therapy to the heart include implantable electrically conductive leads in contact with excitable heart or other body tissue.

The present teachings provide a device and method for delivering an implantable electrically conductive lead to a target site for a use with a cardiac device.

SUMMARY

The present teachings provide a medical apparatus that includes an implantable electrically conductive lead for a cardiac device, the lead having an internal bore terminating at a distal lead opening, and a lead delivery device for delivering the distal end of the lead to a blood vessel during implantation of the lead. The lead delivery device includes a removably anchorable guidewire, and a fixator attached to a distal portion of the guidewire for anchoring the guidewire. The fixator is movable between a compact configuration and an expanded configuration. The fixator is capable of passing through the distal lead opening of the lead in the compact configuration. The fixator is capable of exerting a holding force in the range of about 0.89 to 4.45 N in the lumen of the blood vessel in the expanded configuration.

The present teachings also provide a medical method that includes inserting a distal end of cannulated catheter through cardiac tissue into a main cardiac vessel, attaching an expandable fixator to a distal portion of a guidewire, inserting the guidewire through the catheter, advancing the guidewire past the distal end of the catheter and into a target site in a lumen of a branching vessel, expanding the fixator into the target site, removably anchoring the fixator into the lumen with a holding force in the range of about 0.89 to 4.45 N, and removing the catheter. The method further includes advancing an implantable electrically conductive lead of a cardiac device over the guidewire to the target site without moving the guidewire while tensioning the guidewire, and delivering the distal portion of the lead at the target site.

In another aspect, the present teachings provide a medical apparatus that includes a cardiac device for providing cardiac therapy, or cardiac sensing, or a combination thereof, an implantable electrically conductive lead having proximal and distal ends, the proximal end couplable to the cardiac device, the lead having an internal bore terminating at a distal opening at the distal end, and a lead delivery device for delivering the distal end of the lead to a blood vessel during implantation of the lead. The lead delivery device includes a removably anchorable guidewire, and a fixator attached to a distal portion of the guidewire, the fixator movable between a compact configuration and an expanded configuration. The fixator has a compact width less or equal to about 0.483 mm and is capable of passing through the distal lead opening of the lead in the compact configuration. The fixator has an expanded width up to about 5 mm, and is capable of exerting a holding force in the range of about 0.89 to 4.45 N in the lumen of the blood vessel in the expanded configuration.

In a further aspect, the present teachings provide a medical apparatus comprising a guidewire and a fixator catheter. The fixator catheter comprises a tubular body with a distal portion and a proximal portion. The fixator catheter further comprises a distal opening, a fixator secured to the distal portion, and a body opening arranged between the fixator and the proximal portion. The guidewire is passed through the body opening and the distal opening of the fixator catheter. The fixator is movable between a compact configuration and an expanded configuration.

In yet another aspect, the present teachings provide a medical method comprising passing a guidewire through a fixator catheter. The fixator catheter comprises a tubular body with a distal portion and a proximal portion. The fixator catheter further comprises a distal opening, a fixator secured to the distal portion, and a body opening arranged between the fixator and the proximal portion. The guidewire is passed through the body opening and the distal opening of the fixator catheter. The method further comprises navigating the guidewire and fixator catheter to a desired site. At the desired site, the fixator is expanded to an expanded configuration in order to releasably secure the fixator catheter. An implantable electrically conductive lead of a cardiac device is advanced over the guidewire to the desired site while the fixator is deployed.

Further areas of applicability of the present teachings will become apparent from the description provided hereinafter. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present teachings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present teachings will become more fully understood from the detailed description and the accompanying drawings, wherein:

FIG. 1 is an environmental view of a lead delivery device according to various embodiments of the present teachings;

FIG. 1A is an environmental view of the lead delivery device ofFIG. 1, shown in a second aspect;

FIG. 1B is an enlarged detail of the lead delivery device ofFIG. 1B;

FIG. 2 is a perspective environmental view of the cardiac device with the lead implanted after the lead delivery device ofFIG. 1B is removed;

FIG. 3 is a plan view of a lead delivery device having a fixator according to the present teachings, the lead delivery device shown with the fixator in an expanded configuration;

FIG. 4 is a plan view of a lead delivery device having a fixator according to the present teachings, the lead delivery device shown with the fixator in a compact configuration;

FIGS. 5-11 illustrate various fixators for a lead delivery device according to the present teachings;

FIG. 11A is a top view of the fixator ofFIG. 11;

FIG. 12 is a side view of the fixator ofFIG. 11, illustrating a deployment mechanism;

FIG. 13 is a sectional view of a lead delivery device according to the present teachings with a fixator in a compact configuration inside a lead;

FIG. 14 is the lead delivery device ofFIG. 13, shown with the fixator in an expanded configuration outside the lead;

FIG. 15 is the lead delivery device ofFIG. 13, shown with the fixator partially retracted inside the lead;

FIG. 16 is an end view of a distal end of an electrical lead with an offset distal opening;

FIG. 17 is a plan view of a lead delivery device having a fixator according to the present teachings, the lead delivery device shown with the fixator in a compact configuration;

FIG. 18 is a plan view of a lead delivery device having a fixator according to the present teachings, the lead delivery device shown with the fixator in an expanded configuration;

FIG. 19 is an environmental view of a lead delivery device according to various embodiments of the present teachings;

FIG. 20 is an environmental view of a lead delivery device according to various embodiments of the present teachings;

FIG. 21 is an environmental view of a lead delivery device according to various embodiments of the present teachings; and

FIG. 22 is an environmental view of a lead delivery device according to various embodiments of the present teachings.

DESCRIPTION OF VARIOUS ASPECTS

The following description is merely exemplary in nature and is in no way intended to limit the present teachings, applications, or uses. The present teachings are applicable to any devices that require implantation of electrically conductive leads, including pacemakers, defibrillators or other cardiac devices providing rhythm management, resynchronization therapy or other cardiac therapy.

During left heart (LH) lead delivery methods for implanting cardiac therapy devices, cannulated catheters can be used to provide support and stiffness and allow traceability of the lead into the coronary sinus and more acute branching vessels. For example, in Cardiac Resynchronization Therapy (CRT), a special third lead is implanted via the Coronary Sinus (CS) and positioned in a sub-selected cardiac vein to sense and/or pace the left ventricle in combination with atrial-synchronized, biventricular pacing using standard pacing technology. Following a sensed atrial contraction or atrial-paced event, both ventricles are stimulated to synchronize their contraction. The resulting ventricular resynchronization reduces mitral regurgitation and optimizes left ventricular filling, thereby improving cardiac function.

Guidewires can be used inside the Coronary Sinus and Great Cardiac Vein to gain access to acute side branches. A guidewire is placed into the targeted vessel and the lead is placed over the guidewire and through the catheter. Under existing methods, during lead delivery, a compressive force is maintained by a forward pressure on both the guidewire and lead to allow the lead to travel distally in the branching veins at the target site. The lead itself is designed to provide stiffness and steerability characteristics for the purpose of placement into the vessels. After the LH lead has reached its desired location, the delivery catheters used during the procedure must be removed by slitting because the proximal end of the lead is larger in diameter than the bore of the catheter and the catheter cannot be removed over the lead. The slitting procedure requires a very specific skill set, provides multiple avenues for user error and places constraints on catheter design, construction and use.

In contrast to the existing method described above, the present teachings provide a lead delivery device method that does not require slitting the catheter. The lead delivery device includes a guidewire that can be temporarily anchored in a sub-selected acute coronary vein branch during lead delivery. Fixation can be provided by a fixator that expands from a compact configuration of very low profile fitting inside a lead to an expanded configuration having a dimension large enough to allow sufficient tension to be placed on the guidewire to enable lead delivery over the guidewire in a zip-line or rope-climbing manner, as described below. The guidewire with the fixator in the compact configuration can be guided through the catheter to the target site. The catheter can then be removed before the lead is advanced over the guidewire. After the lead is implanted, the fixator is returned to the compact configuration and removed together with the guidewire through the implanted lead without slitting.

An exemplarylead delivery device100 according to the present teachings is illustrated during lead delivery of an electricallyconductive lead200 inFIGS. 1, 1A and 1B. An implantedlead200 is shown inFIG. 2, after thelead delivery device100 is removed. Thelead200 can be cannulated having an internal bore orlumen204, aproximal portion201, and adistal portion202. Theproximal portion201 can be coupled with aconnector pin207 to a connector block of acardiac device290, with which thelead200 is in electrical communication. Acatheter250 having aproximal end252 and adistal end254 can be used to insert the lead delivery device initially throughheart tissue80, as shown inFIG. 1.

Thelead delivery device100 can include aguidewire102 entering aproximal end252 of thecatheter250 and exiting through adistal end254 of thecatheter250 as shown inFIG. 1. Theguidewire102 can be solid or cannulated with abore103, as shown inFIG. 12. Theguidewire102 can include adistal portion104 terminating in atip106. Thedistal portion104 can be flexible for ease in guiding theguidewire102 through tortuous blood vessels to atarget site82, such as a branching vein branching off the coronary sinus or other main blood vessel. Thelead delivery device100 can include afixator150 coupled to theguidewire102. Thefixator150 can assume an expanded or deployed configuration for anchoring theguidewire102 near atarget site82 during lead delivery and implantation, as shown inFIGS. 3, and 5-11, illustrating various fixator aspects. Referring toFIG. 1, thecatheter250 can be removed by retracting thecatheter250 fromheart tissue80 after the lead delivery device is anchored at thetarget site82. No slitting of thecatheter250 is required for removal of thecatheter250. After thecatheter250 is removed, thelead200 can be guided over theguidewire102 to thetarget site82, as discussed further below.

Thefixator150 can be returned to a compact or undeployed configuration, such as the configuration illustrated inFIG. 4, for retracting and removing theguidewire102 after lead delivery and implantation. The maximum dimension, diameter or width of thefixator150 in the expanded configuration is denoted as L1 and in the contracted configuration as L2, as illustrated inFIGS. 3 and 4 for a fixator in the form of a balloon.

FIGS. 5-11 illustratevarious fixators150 in their expanded configuration showing the maximum dimension L1 for eachfixator150. The dimension L1 is selected to achieve a fixation force within a blood vessel of an amount that allows theguidewire102 to be pulled in tension without being dislodged from the blood vessel while the lead is pushed over theguidewire102, as discussed below. The fixation force F can be equal to or greater than about 2.24 N, or about 0.5 lbs, for achieving sufficient fixation within the blood vessel wall. The fixation force F can generally be in the range of about 0.89 to 4.45 N (or 0.2 to 1.0 lbs), depending on various factors, including the geometry of the branching vessel. The deployed width or dimension L1 corresponding to this fixation force F can be 5 mm, while the undeployed width or dimension L2 can be maintained to equal to or less than about 0.019 inches, or about 0.483 mm, to allow easy passage through commercially available leads, such as those used with medical devices available from Medtronic, Inc., of Minneapolis, Minn.

Referring toFIGS. 13-15, thedistal portion202 of anelectrical lead200 is illustrated in connection with aguidewire102 having a width L4 and afixator150 having an undeployed width L2. Thelead200 is conductive and can deliver therapy in the form of electric energy at thetarget site82. In one aspect, thelead200 can also sense and relay information about electrical activity from theheart tissue80 ortarget site82 back to thecardiac device290. Thelead200 can have an internal bore orlumen204, an internal coil or otherconductive element210 and atip portion206 that can be an electrode tip with or without a seal. Thetip portion206 can define adistal opening205 with width L3. In one aspect, thetip portion206 can include a seal with flexible flaps, not shown. The guidewire width L4 can be about 0.346 mm (or about 0.014 inches) for providing steerability, stiffness and sufficient support for lead delivery over theguidewire102.

The compact width L2 of thefixator150 can be equal to or less than the width L3 of thedistal opening205, such that thefixator150 can be pushed through thedistal opening205 in the direction C, as shown inFIG. 13. In one aspect thedistal opening205 can be offset relative to a central longitudinal axis of thelead200, as shown inFIG. 16. Thefixator150 can be deployed to the expanded configuration within theblood vessel90 such that the expanded width L1 of thefixator150 can press against theinternal lumen92 of theblood vessel90 with a holding force F, as discussed above, for temporarily anchoring theguidewire102 into theblood vessel90, as shown inFIG. 14.

Various fixators150 can be used to temporarily and removably anchor theguidewire102 in thelumen92 of ablood vessel90. Referring toFIGS. 3 and 4, thefixator150 can be a balloon having first and second ends111,113 attached to theguidewire102. The balloon can be inflated, for example, with a gas or fluid, including a gel or other liquid, provided by a syringe through avalve110 at a proximal end of theguidewire102. In another aspect, a luerlock inflation port120 can be coupled to theguidewire102 for deploying the balloon. The balloon can be made from a polyblend material which is heated and stretched, placed around theguidewire102 and bonded at first and second ends111,113 of the balloon onto theguidewire102 with small amounts of cyanoacrylate adhesive, for example. A radio-opaque marker108 in the form of a band can be placed adjacent the second (proximal)end113 of the balloon for visualization during guided navigation. The radio-opaque marker108 can also be in the form of a radio-opaque balloon coating or radio-opaque fluid filling the balloon. In another aspect, the balloon-type fixator150 can include an etched fixation surface with etchedsurface fixation formations154 in the form of bumps, rings, etc., as illustrated inFIGS. 5 and 7. In another aspect, thefixator150 can be a balloon with spiral or helical or otherwise curved configuration for maintaining a percentage of blood flow through theblood vessel90 and aiding fixation in tortuous anatomy.

Referring toFIGS. 9-12, thefixator150 can also be in the form of a mechanical anchor with deployablestraight wings160, as shown inFIG. 9, orcurved wings160, as shown inFIG. 10, or a pinwheel-type fixator150, as shown inFIGS. 11 and 11A. Themechanical anchor150 can be deployed with alongitudinal actuator170 in the form of a wire or string or other elongated member passing through thebore103 of a cannulatedguidewire102. Referring toFIG. 12, for example, theanchor wings160 can pivot about apivot pin124 connected to theactuator170 and can be deployed to the expanded position in the direction of arrows E by pulling theactuator170 in the direction of arrow D. In other aspects, thefixator150 can be in the form of a superelastic wire, such as nitinol, and can be pre-shaped to expand to an anchorable configuration within theblood vessel90.

In another aspect,fixators150 including polymer lobes or superelastic or memory-shape wire can be used. Further, the dimensions of thefixator150, including the expanded width L1 and the compact width L2 can be selected to match the range of most common vessel sizes. The expanded shape of thefixator150 can be selected to increase the contact area with the blood vessel and or provide multiple contact surfaces for increasing holding force and stability, as shown inFIGS. 6, 8, and 10, for example. The expanded shape can have a symmetric profile, as shown inFIG. 9, for example, or a non-symmetric profile, as shown inFIG. 6, for example. In other aspects, the expanded shape can have an asymmetric profile for anchoring unidirectionally rather than bi-directionally.

As discussed above, deployment of thefixator150 and anchoring can occur after the cannulation of the coronary sinus CS with thecatheter250 and after sub-selection of a side branch with theguidewire102. Further, fixation of theguidewire102 by theexpandable fixator150 can be maintained during lead delivery and terminated after thelead200 is delivered to the target vessel at thetarget site82. At the discretion of the operating physician, fixation and release can occur multiple times during the medical procedure. Damage to thelead200 during fixation can be avoided because fixator expansion and fixation occurs outside thelead200.

It should be appreciated, that according to the present teachings thelead delivery device100 with either a balloon ormechanical fixator150 is configured and designed to function as a wedge or anchoring device for temporarily anchoring theguidewire102 during the implantation of theelectrical lead200.

Referring toFIGS. 1-2, and 13-15, the cannulatedcatheter250 can be inserted throughheart tissue80 into a coronary sinus CS, cardiac great vein or other main vessel stopping short of atarget site82 that is located in a sub-selected acute branchingvessel90. Theguidewire102 with thefixator150 in the undeployed compact configuration can be inserted through thecatheter250, advanced past thedistal end254 of thecatheter250 through a main vessel to thetarget site82 in the branchingvessel90, as shown inFIG. 1. Thefixator150 can then be deployed and become anchored in thelumen92 of the branchingvessel90 with a holding force F, as discussed above. Thecatheter250 can then be retracted and completely removed with no slitting procedure. Thelead200 can be guided over the anchoredguidewire102 until thedistal portion202 of thelead200 reaches thetarget site82, as shown inFIG. 1B. Thelead200 can be advanced by keeping theguidewire102 in tension while pushing thelead200 in the direction of thefixator150. When thedistal portion202 of thelead200 reaches thetarget site82, thefixator150 can be returned to its undeployed compact configuration and be retracted through thelumen204 of thelead200, as shown inFIG. 15. Thelead200 can remain installed in thetarget site82, as shown inFIG. 2, or advanced more distally in the branchingvessel90 beyond theoriginal target site82 after the removal of theguidewire102.

It will be appreciated that, in other aspects, thecatheter250 may be retained during the entire lead delivery procedure, such that the lead is inserted through thecatheter250 and over theguidewire102, but in such cases slitting of thecatheter250 may not be avoided after lead implantation. In further aspects, theguidewire102 and thelead200 can be inserted through thecatheter250 in any order, i.e., guidewire102 first, or lead200 first or at the same time. In all aspects, however, theguidewire102 can first be advanced to thetarget site82 of a branchingvessel90 and thefixator150 be deployed at thetarget site82. Only then thedistal portion202 of thelead200 is advanced to thetarget site82 by pushing thelead200 over theguidewire102 toward thetarget site82, while theguidewire102 remains fixed. Specifically, thelead200 can be advanced to thetarget site82 in a climbing-like or zip line-like manner by pulling and tensioning theguidewire102 while theguidewire102 remains anchored with the deployedfixator150 at thetarget site82.

Referring now toFIG. 17, alead delivery device300 according to some embodiments of the present disclosure is illustrated.Lead delivery device300 comprises aguidewire302 andfixator catheter304.Guidewire302 may comprise a solid wire (as illustrated) or be cannulated, and includesproximal portion344 anddistal portion342. Thefixator catheter304 is a cannulated catheter comprising atubular body310 with adistal portion320 andproximal portion340. Afixator312 is secured on thedistal end320 offixator catheter304. InFIGS. 17-22,fixator312 comprises an inflatable balloon, although any other form of fixator may be utilized, as described above.

Guidewire302 passes throughfixator catheter304 such that theguidewire302 is encased within thetubular body310 in at least a portion of thedistal portion320 of thefixator catheter304. In the illustrated embodiments, this is accomplished by passing thedistal portion342 of theguidewire302 through the body opening316 offixator catheter304 such that it extends through thedistal opening314. In this manner, theguidewire302 andfixator catheter304 are in communication at theirdistal portions342,320, while being separate at theirproximal portions344,340.

Referring now toFIG. 18,lead delivery device300 is shown in the condition wherefixator312 is expanded. In the illustration,fixator312 comprises an inflatable balloon that may be expanded by a gas or fluid, as described more fully above. In some embodiments, thetubular body310 of thefixator catheter304 includes a lumen (not shown) that is in communication with theinflatable balloon312 andproximal end340. By providing a pressurized gas or fluid to theballoon312, thefixator312 is expanded to the expanded configuration. In the expanded configuration, the pressure insideballoon312 will exert a force on a compressible orcollapsible portion313 oftubular body310. In the illustrated embodiment, thecompressible portion313 is a portion of the lumen of the fixator catheter within the inflatable balloon, however, thecompressible portion313 may comprise a lumen of the balloon itself or other arrangement. The force exerted byinflatable balloon312 onportion313 oftubular body310 will cause thatportion313 to compressguidewire302 such that guidewire302 is secured tofixator catheter304.Portion313 may be formed by providing a thinner wall inportion313 than is utilized in the remainder oftubular body310. Alternatively,portion313 may be formed of a different material than that used to form the rest oftubular body310, or any other alternative structure may be utilized (such as, adding a constrictive device or other securing mechanism). While the illustration inFIG. 18 shows aninflatable balloon312 and a compressible orcontract portion313 oftubular body310 to secure theguidewire302 tofixator catheter304, alternative structures and fixators may be substituted such that theguidewire302 andfixator catheter304 are secured together in the expanded configuration, while remaining independently movable in the compact configuration.

Referring now toFIGS. 19-22, a method for usinglead delivery device300 to implant an implantable electricallyconductive lead360 within ablood vessel350 is illustrated. Similar toFIG. 1,FIGS. 19-20 show thelead delivery device300 utilized to implant implantable electricallyconductive lead360 within the coronary sinus CS ofheart tissue80. Adelivery catheter250 having aproximal end252 anddistal end254 may be utilized to assist in the delivery ofguidewire302 andfixator catheter304 to a target or desiredsite82. Thefixator catheter304, withguidewire302 passed therein, is inserted throughcatheter250 and navigated to a position within the desiredsite82. Upon delivery to desiredsite82,fixator catheter304 deploys itsfixator312 to secureguidewire302 andfixator catheter304 withinblood vessel350. In the expanded configuration,fixator312 exerts a force, as described above, upon the wall ofblood vessel350 sufficient to anchor both theguidewire302 andfixator catheter304 in the desiredsite82 whiledelivery catheter250 is removed and/or implantable electricallyconductive lead360 is delivered to desiredsite82, e.g., viaguidewire302.

In the illustrations ofFIGS. 19 and 20,delivery catheter250 is shown as being present within theheart tissue80 during delivery oflead360. As shown inFIG. 19, in the expandedconfiguration fixator312 compresses or collapsesportion313 offixator catheter304 such that guidewire302 is fixedly secured withinfixator catheter304, as described more fully above. Alternatively, as shown inFIG. 20, guidewire302 may be removed fromfixator catheter304 beforefixator312 is expanded.Fixator312 may then be expanded to fixedlysecure guidewire302 betweenfixator312 and the wall ofblood vessel350. Onceguidewire302 is fixedly secured withinblood vessel350, implantable electricallyconductive lead360 may be delivered to desiredsite82 by, e.g., traveling overguidewire302. With theguidewire302 secured, the risk of thelead360 being delivered incorrectly, i.e., outside of desiredsite82, due to unintentional movement ofguidewire302 is reduced.

Oncelead360 is delivered to the desiredsite82, thefixator312 may be contracted to a compact configuration (as shown inFIG. 17, for example) and bothguidewire302 andfixator catheter304 may be removed from desiredsite82 andheart tissue80. In some embodiments,fixator312 may be utilized to securelead360 againstblood vessel wall350 whileguidewire302 is removed (see, e.g.,FIG. 22). In this manner, it can be ensured that there is no unanticipated movement oflead360 from desiredsite82 whileguidewire302 is removed from the patient's body.

Referring now toFIGS. 21 and 22, a method of finely adjusting the position ofguidewire302 and lead360 is illustrated.FIG. 21 shows fixator312 in the expanded condition whereinguidewire302 is secured betweenfixator312 and the wall ofblood vessel350. This is accomplished, for example, by deliveringlead delivery device300 to the desiredsite82 and then removing guidewire302 fromdistal opening314 and body opening316 offixator catheter304. Theguidewire302 may be pulled out of communication withfixator catheter304 by pushing onfixator catheter304 until thedistal portion342 ofguidewire302 is pulled out of and exitsbody opening316. Then, guidewire302 may be pushed past thedistal portion320 offixator catheter304, as illustrated.Fixator312 may be expanded to secureguidewire302 against the wall ofblood vessel350 and implantable electricallyconductive lead360 can then be navigated to desiredsite82 by, for example, traveling overguidewire302 throughopening364.

The position of implantable electricallyconductive lead360 and guidewire302 may be finely adjusted with the selective use offixator catheter304.Fixator312 may be expanded to secure guidewire302 (as shown inFIG. 21) such that the position oflead360 may be adjusted. Alternatively, as shown inFIG. 22,fixator catheter304 may be moved such thatfixator312 is immediately adjacent the body oflead360.Fixator312 may then be expanded to securelead360 withinblood vessel350. Withlead360 secured, the position ofguidewire302 may be adjusted without the possibility of movinglead360. In this manner, a user may alternate between securing theguidewire302 or lead360 at a certain position, while adjustingunsecured lead360 orguidewire302, respectively, and thus more accurately and simply adjust the positioning oflead360 within desiredsite82.

The foregoing discussion discloses and describes merely exemplary arrangements of the present teachings. Furthermore, the mixing and matching of features, elements and/or functions between various embodiments is expressly contemplated herein, so that one of ordinary skill in the art would appreciate from this disclosure that features, elements and/or functions of one embodiment may be incorporated into another embodiment as appropriate, unless described otherwise above. Moreover, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. One skilled in the art will readily recognize from such discussion, and from the accompanying drawings and claims, that various changes, modifications and variations can be made therein without departing from the spirit and scope of the present teachings as defined in the following claims.

Claims (29)

What is claimed is:

1. A medical apparatus, comprising:

a guidewire;

a fixator catheter comprising a tubular body with a distal portion and a proximal portion, the fixator catheter further comprising a body opening and a distal opening at a distal end of the fixator catheter, wherein the body opening is defined through a portion of the tubular body of the fixator catheter to a lumen extending through the tubular body of the fixator catheter including the distal and proximal portions thereof and which lumen terminates at the distal opening, and further wherein at least a portion of the body opening is defined through the tubular body of the fixator catheter at the distal portion thereof; and

a fixator secured to the distal portion of the fixator catheter; and wherein:

the guidewire passes through the body opening of the fixator catheter, through a portion of the tubular body at the distal portion of the fixator catheter, and through the distal opening of the fixator catheter, and further wherein the guidewire and the fixator catheter are in communication at the distal portion of the fixator catheter with at least a portion of the guidewire extending through and within a portion of the tubular body of the fixator catheter while the guidewire is separate and outside of the tubular body of the fixator catheter at the proximal portion of the fixator catheter, and the fixator is movable between a compact configuration and an expanded configuration, wherein the fixator is configurable to secure a portion of the guidewire to the fixator catheter in the lumen within the portion of the tubular body at the distal portion of the fixator catheter in the expanded configuration.

2. The medical apparatus ofclaim 1, wherein the guidewire is secured to the fixator catheter when the fixator is in the expanded configuration.

3. The medical apparatus ofclaim 2, wherein the guidewire is movable in relation to the fixator catheter when the fixator is in the compact configuration.

4. The medical apparatus ofclaim 1, wherein the fixator comprises an inflatable balloon comprising etched surface fixation formations.

5. The medical apparatus ofclaim 1, wherein the fixator comprises an inflatable balloon comprising a helical or spiral configuration for following a tortuous path.

6. The medical apparatus ofclaim 1, wherein the fixator comprises a mechanical anchor having deployable parts.

7. The medical apparatus ofclaim 6, wherein the deployable parts comprise movable wings.

8. The medical apparatus ofclaim 6, wherein the fixator comprises a pinwheel.

9. The medical apparatus ofclaim 1, wherein the body opening is defined through the tubular body of the fixator catheter proximate the fixator.

10. A medical apparatus, comprising:

a guidewire; and

a fixator catheter comprising a tubular body with a distal portion and a proximal portion, the fixator catheter further comprising:

a distal opening at a distal end of the fixator catheter;

a fixator secured to the distal portion of the fixator catheter; and

a body opening arranged between the fixator and the proximal portion, wherein the body opening is defined through a portion of the tubular body of the fixator catheter to a lumen extending through the tubular body of the fixator catheter including the distal and proximal portions thereof and which lumen terminates at the distal opening, and further wherein at least a portion of the body opening is defined through the tubular body of the fixator catheter at the distal portion thereof, wherein:

the guidewire passes through the body opening of the fixator catheter, through a portion of the tubular body at the distal portion of the fixator catheter, and through the distal opening of the fixator catheter, and further wherein the guidewire and the fixator catheter are in communication at the distal portion of the fixator catheter with at least a portion of the guidewire extending through and within a portion of the tubular body of the fixator catheter while the guidewire is separate and outside of the tubular body of the fixator catheter at the proximal portion of the fixator catheter, and

the fixator is movable between a compact configuration and an expanded configuration, wherein the fixator is configurable to secure a portion of the guidewire to the fixator catheter in the lumen within the portion of the tubular body at the distal portion of the fixator catheter in the expanded configuration; and

further wherein the fixator comprises an inflatable balloon and the guidewire passes through a compressible portion of the fixator catheter within the inflatable balloon.

11. The medical apparatus ofclaim 10, wherein the guidewire is secured to the fixator catheter when the fixator is in the expanded configuration.

12. A medical apparatus according toclaim 10, wherein the compressible portion of the fixator catheter is compressible to secure the guidewire to the fixator catheter.

13. A medical apparatus according toclaim 10, wherein the compressible portion of the fixator catheter is compressed around the guidewire responsive to inflation of the balloon.

14. A method for delivering a medical apparatus, comprising:

providing a fixator catheter comprising a tubular body with a distal portion and a proximal portion, wherein a lumen extends through the tubular body of the fixator catheter including the distal and proximal portions thereof, and further wherein the lumen terminates at a distal opening at a distal end of the fixator catheter;

passing a guidewire through a body opening of a fixator catheter, through a portion of the tubular body at the distal portion of the fixator catheter, and through the distal opening of the fixator catheter terminating the lumen extending through the tubular body of the fixator catheter, wherein the body opening is defined through a portion of the tubular body of the fixator catheter to the lumen extending through the tubular body of the fixator catheter, and wherein at least a portion of the body opening is defined through the tubular body of the fixator catheter at the distal portion thereof, a fixator being secured to the distal portion of the fixator catheter;

navigating the guidewire to a desired site;

navigating the fixator catheter to the desired site, wherein the guidewire and the fixator catheter are in communication at the distal portion of the fixator catheter with at least a portion of the guidewire extending through and within a portion of the tubular body of the fixator catheter while the guidewire is separate and outside of the tubular body of the fixator catheter at the proximal portion of the fixator catheter;

expanding the fixator to an expanded configuration to releasably secure a portion of the guidewire to the fixator catheter in the lumen within the portion of the tubular body at the distal portion of the fixator catheter and releasably secure the fixator catheter, and the guidewire secured thereto, within a blood vessel; and

advancing an implantable electrically conductive lead of a cardiac device over the guidewire that is separate and outside of the tubular body of the fixator catheter at the proximal portion of the fixator catheter toward the body opening while the fixator is deployed.

15. The method ofclaim 14, further comprising:

contracting the fixator to a compact configuration to release the fixator catheter; and

removing the guidewire and fixator catheter from the desired site.

16. The method ofclaim 14, wherein the guidewire is secured to the fixator catheter in the expanded configuration.

17. The method ofclaim 14, wherein the guidewire is movable in relation to the fixator catheter in the compact configuration.

18. The method ofclaim 14, wherein the fixator comprises an inflatable balloon comprising etched surface fixation formations.

19. The method ofclaim 14, wherein the fixator comprises an inflatable balloon comprising a helical or spiral configuration for following a tortuous path.

20. The method ofclaim 14, wherein the fixator comprises a mechanical anchor having deployable parts.

21. The method ofclaim 20, wherein the deployable parts comprise movable wings.

22. The method ofclaim 20, wherein the fixator comprises a pinwheel.

23. The method ofclaim 14, further comprising:

contracting the fixator to a compact configuration to release the fixator catheter;

removing the guidewire from the fixator catheter;

expanding the fixator to the expanded configuration to releasably secure the implantable electrically conductive lead;

adjusting the guidewire within the desired site;

contracting the fixator to the compact configuration to release the implantable electrically conductive lead;

expanding the fixator to the expanded configuration to releasably secure the guidewire and fixator catheter; and

adjusting the implantable electrically conductive lead within the desired site.

24. The method ofclaim 14, further comprising:

navigating a delivery catheter adjacent the desired site; and

removing the delivery catheter from adjacent the desired site without slitting the delivery catheter.

25. The method ofclaim 24, wherein removing the delivery catheter occurs while the fixator is in the expanded configuration.

26. The method ofclaim 24, wherein removing the delivery catheter comprises removing the delivery catheter prior to advancing the implantable electrically conductive lead toward the body opening over the guidewire.

27. The method ofclaim 14, wherein the body opening is defined through the tubular body of the fixator catheter proximate the fixator.

28. A method for delivering a medical apparatus, comprising:

providing a fixator catheter comprising a tubular body with a distal portion and a proximal portion, wherein a lumen extends through the tubular body of the fixator catheter including the distal and proximal portions thereof, and further wherein the lumen terminates at a distal opening at a distal end of the fixator catheter;

passing a guidewire through a body opening of a fixator catheter, through portion of the tubular body at the distal portion of the fixator catheter, and through the distal opening of the fixator catheter terminating the lumen extending through the tubular body of the fixator catheter, wherein the body opening is defined through a portion of the tubular body of the fixator catheter to the lumen extending through the tubular body of the fixator catheter, and wherein at least a portion of the body opening is defined through the tubular body of the fixator catheter at the distal portion thereof, a fixator being secured to the distal portion of the fixator catheter and the body opening being arranged between the fixator and the proximal portion;

navigating the guidewire to a desired site;

navigating the fixator catheter to the desired site, wherein the guidewire and the fixator catheter are in communication at the distal portion of the fixator catheter with at least a portion of the guidewire extending through and within a portion of the tubular body of the fixator catheter while the guidewire is separate and outside of the tubular body of the fixator catheter at the proximal portion of the fixator catheter;

expanding the fixator to an expanded configuration to releasably secure a portion of the guidewire to the fixator catheter in the lumen within the portion of the tubular body at the distal portion of the fixator catheter and releasably secure the fixator catheter, and the guidewire secured thereto, within a blood vessel; and

advancing an implantable electrically conductive lead of a cardiac device over the guidewire that is separate and outside of the tubular body of the fixator catheter at the proximal portion of the fixator catheter toward the body opening while the fixator is deployed;

wherein the fixator comprises an inflatable balloon and the guidewire passes through a compressible portion of the fixator catheter within the inflatable balloon.

29. The method ofclaim 28, wherein the guidewire is secured to the fixator catheter when the fixator is in the expanded configuration.

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